search
Back to results

Quantifying the Venous Congestion Curve of a Tissue Oximetry Device

Primary Purpose

Post-Op Complication, Skin Flap Necrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ViOptix
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Op Complication

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 - 65 volunteers

Exclusion Criteria:

  • Subjects with a history of major cardiac disease, peripheral vascular disease including (vascular insufficiency), Raynaud syndrome, blood dyscrasias, pain syndromes, neurologic conditions, major upper extremity soft tissue trauma or previous vascular injury

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ViOptix T.Ox

Arm Description

ViOptix T.Ox machine is used to measure the oxygenation of composite tissue.

Outcomes

Primary Outcome Measures

Change in transcutaneous oximetry (StO2)
the change in transcutaneous oximetry (StO2) over time of vascular occlusion test - an StO2 greater than 55 mmHg is considered normal regardless of the site of measurement, whereas a value of 40 mmHg is the critical value below which wound healing is impaired and ischemia develops.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2022
Last Updated
October 12, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05592145
Brief Title
Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
Official Title
Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. ViOptix probes will be secured to the arm and hand. The recording process on the ViOptix machine will begin and obtain baseline StO2 levels for 5 minutes. After 5 minutes, a blood pressure cuff will be inflated on one arm. This blood pressure cuff will be left inflated for 10-20 minutes. Every 2 minutes a pulse check or doppler exam will be performed at your wrist. Last, the cuff will be deflated and the you will be free to leave the study room.
Detailed Description
The rate of decline and pattern seen in tissue oxygenation as quantified by a NIRS device (ViOptiox T.Ox) can be quantified and described by a mathematical model which will allow earlier detection and identification of venous congestion in tissue. The vascular occlusion test has been established as a safe and accurate model to induce various states of vascular insufficiency and occlusion. Specifically the vascular occlusion test has been demonstrated to be an accurate model for inducing venous insufficiency on awake and aware patients. This study will aim to analyze the StO2 data output of the ViOptix in order to establish the earliest signs of tissue failure in various states of vascular compromise. The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. The data collected will be used to formulate a mathematical model which will allow earlier detection and identification of venous congestion in tissue. Identifying these specific patterns will help to establish an evidence-based approach in recognizing specific problems and patterns associated with tissue compromise that can guide physicians to consider earlier flap salvage measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication, Skin Flap Necrosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The ViOptix machine will be used to measure the oxygenation of composite tissue.
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ViOptix T.Ox
Arm Type
Other
Arm Description
ViOptix T.Ox machine is used to measure the oxygenation of composite tissue.
Intervention Type
Device
Intervention Name(s)
ViOptix
Intervention Description
ViOptix machine
Primary Outcome Measure Information:
Title
Change in transcutaneous oximetry (StO2)
Description
the change in transcutaneous oximetry (StO2) over time of vascular occlusion test - an StO2 greater than 55 mmHg is considered normal regardless of the site of measurement, whereas a value of 40 mmHg is the critical value below which wound healing is impaired and ischemia develops.
Time Frame
Hour 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 - 65 volunteers Exclusion Criteria: Subjects with a history of major cardiac disease, peripheral vascular disease including (vascular insufficiency), Raynaud syndrome, blood dyscrasias, pain syndromes, neurologic conditions, major upper extremity soft tissue trauma or previous vascular injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Llull, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantifying the Venous Congestion Curve of a Tissue Oximetry Device

We'll reach out to this number within 24 hrs